A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy
NCT ID: NCT06706752
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-01-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Treatment Group
Shengbai Oral Formula
Shengbai Oral Formula contains 11 herbs: Folium Epimedii, Fructus Lycii, Radix Astragali, Caulis Spatholobi, Radix Rubiae, Rhizoma Phragmitis, Fructus Psoraleae, Radix Angelicae Sinensis, Radix Ophiopogonis,, Radix et Rhizoma Glycyrrhizae, Radix Aconiti Lateralis Preparata (Processed). It is taken by mouth three times per day for 14 days.
Placebo Group
Inactive Placebo
Inactive placebo will be taken by mouth three times per day for 14 days.
Interventions
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Shengbai Oral Formula
Shengbai Oral Formula contains 11 herbs: Folium Epimedii, Fructus Lycii, Radix Astragali, Caulis Spatholobi, Radix Rubiae, Rhizoma Phragmitis, Fructus Psoraleae, Radix Angelicae Sinensis, Radix Ophiopogonis,, Radix et Rhizoma Glycyrrhizae, Radix Aconiti Lateralis Preparata (Processed). It is taken by mouth three times per day for 14 days.
Inactive Placebo
Inactive placebo will be taken by mouth three times per day for 14 days.
Eligibility Criteria
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Inclusion Criteria
2. A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
3. Chemotherapy is given at a minimum of every 2 weeks
4. At least 30 days past radiation therapy
5. Nonpregnant and use of method of contraception per the treating clinician standard of care
6. Life expectancy \> 3 months
7. Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
8. Baseline ECOG ≤ 2
9. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study including all scheduled evaluations and required tests
Exclusion Criteria
2. eGFR \<60
3. Platelets \< 75,000
4. Hb \<8.0
5. ANC \<1000
6. Documentation of a bone marrow transplant
7. Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
8. Documentation of current seizure disorder
9. Documentation of new cardiac arrhythmias and myocardial infarction
10. Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
11. Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
12. Documentation of a current drug abuse disorder
13. Current participation in other clinical trial
18 Years
80 Years
ALL
No
Sponsors
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Sutter Health
OTHER
Responsible Party
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Amy Matecki
Principal Investigator and Holistic/Integrative Medicine Physician
Locations
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Sutter Health
Oakland, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2052995
Identifier Type: -
Identifier Source: org_study_id
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